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NCT06415591Not yet recruiting

Auricular Neuromodulation in Veterans With Fibromyalgia, A Randomized, Sham-Controlled Study

Auricular Neuromodulation in Veterans With Fibromyalgia: A Randomized, Sham-Controlled Study
VA Office of Research and DevelopmentClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
Fibromyalgia
Drug/Device/Intervention
Percutaneous electrical nerve field stimulation
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
VA Office of Research and Development
Location
Decatur, United States of America
Timeline & enrollment
Phase
N/A
Start date
Oct 01, 2024
End date
Oct 01, 2028
Enrollment
240 participants
Primary outcome

Improvements in Clinical Pain (DVPRS),Improvements in Clinical Pain (Self-reported analgesic consumption)

Summary

PENFS (percutaneous electrical nerve field stimulation) is an FDA-approved acupuncture-like
 therapy applied to the external ear targeting several cranial nerve branches including the
 auricular branch of the vagus nerve to improve pain, physical function, and reduce symptoms
 of opioid withdrawal. PENFS has been previously shown to provide improvements in
 fibromyalgia, a difficult to treat chronic pain syndrome, which correlate with changes
 observed using a special kind of MRI called resting state functional connectivity MRI
 (rs-fcMRI) that evaluates brain activity at rest. The goals of this study are to rigorously
 test the initial promising results of PENFS in a much larger group of Veterans suffering from
 fibromyalgia and to identify potential mechanisms of PENFS effects. Further developing
 non-pharmacologic therapies for pain can help to improve quality of life and function for
 those suffering from fibromyalgia and decrease reliance on opioids and other drugs that have
 numerous side effects for individuals suffering from chronic pain.

ICD-10 classifications
FibromyalgiaMyalgiaFibrothoraxCervicalgiaEpidemic myalgia
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06415591
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06415591 through Pure Global AI's free database. This phase not specified trial is sponsored by VA Office of Research and Development and is currently Not yet recruiting. The study focuses on Fibromyalgia. Target enrollment is 240 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.